Assessing the Efficacy of Elixirium Thymi Compositum in the Treatment of Acute Bronchitis in Pediatric Patients (EXOTIC): A Double-blind, Randomized, Placebo-controlled, Phase 4 Study
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Bronchitis Severity Score
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of Elixirium thymi compositum (Formulae Normales (FoNo) VIII.) compared to a placebo in children between 6 and 17 years old to treat their acute bronchitis. The main question it aims to answer is: Is Elixirium thymi compositum (FoNo VIII.) safe and effective in the treatment of acute bronchitis compared to placebo?
详细描述
Acute bronchitis is a common disease caused mainly by viral infections. Although there is a standard symptomatic therapy for it, antibiotics are often prescribed, which contributes to an increase in antibiotic resistance. Elixirium thymi compositum (FoNo VIII.) might be an alternative therapeutic option.
The aim is to establish the role of this product by evaluating its clinical efficacy and safety, meanwhile reducing the misuse of antibiotics in treating this condition.
This is a randomized, controlled, double-blinded, two-arm multicenter phase 4 trial. Eligible patients will be pediatric individuals between 6 and 17 years old diagnosed with acute bronchitis. The trial will enroll at least 56 eligible participants with a Total Bronchitis Severity Score (BSS) ranging from 5 to 12 points. Participants will be assigned randomly in a 1:1 ratio to receive either Elixirium thymi compositum at an age-dependent dosage (18-30 ml daily) for 5 days or a placebo with the same concentration and duration.
The trial's primary endpoint is the assessment of symptom improvement in acute bronchitis, as indicated by changes in the BSS score on Day 7. Secondary endpoints include evaluating use of concomitant medications and dietary supplements, safety and tolerability through reported adverse events, and the necessity of antibiotic usage. These secondary endpoints will provide deeper insights into the differences between the treatment and placebo groups. The primary and secondary endpoints will be monitored throughout a follow-up period of 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 6-17 years,
- •diagnosis of acute bronchitis and the Total Bronchitis Severity Score of the patient is between 5-12 points,
- •informed consent form and patient information leaflet signed by the patient and the parent or legal guardian, and
- •no pregnancy, no planned pregnancy, and no breastfeeding.
排除标准
- •allergy to the active ingredients or any other components of Elixirium thymi compositum,
- •hypersensitivity to plants of the Lamiaceae family,
- •chronic respiratory diseases such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease,
- •pneumonia in the last year,
- •a history of recurrent or severe laryngotracheal stenosis due to inflammation,.
- •active or chronic inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or infectious enterocolitis,
- •heart failure (New York Heart Association Class II-IV),
- •smoking (the patient currently smokes or has smoked at least one cigarette, cigar, or pipe daily),
- •a diagnosis or history of lung cancer,
- •a history of lung or chest surgery,
- •any viral infection in the last 6-8 weeks,
- •immunostimulant medications, antibiotics, or systemic steroid treatments in the past month,
- •antihistamines, expectorants, or local steroids applied in the last two weeks,
- •hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency,
- •taking or planning to take hormonal contraceptives within the next 2 weeks
- •chronic liver disease (e.g., cirrhosis) or acute hepatitis.
结局指标
主要结局
Bronchitis Severity Score
时间窗: From enrollment to the end of study at 7 days, measured on Day 0, Day 3 and Day 7.
The Bronchitis Severity Scale (BSS) is a tool that assesses the five most important symptoms of acute bronchitis: cough, sputum production, wheezing, chest pain on coughing, and dyspnea. The assessment is based on the examiner's clinical judgment and patient feedback. The examiner rates each parameter of the BSS on a 5-point verbal scale from 0 to 4 (0: absent; 1: mild; 2: moderate; 3: severe; 4: very severe). The total BSS score is the sum of the ratings of the five symptoms, with a maximum score of 20.
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](From enrollment to the end of study at 7 days.)
- Quality of life in acute bronchitis(From enrollment to the end of study at 7 days.)